REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

{0}------------------------------------------------ ## KUS 1521 # 510(k) Summary as required by 807.92 #### 1. Company Identification JUN 2 8 2005 KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 Ishikawa machi Hachioji-shi, Tokyo 192-8505, Japan Tel: +81-426-60-9607 Fax: +81.426-60-9588 - 2. Official Correspondent Koji Kubo(Mr.) Department TS Advanced Technology Division R & D Center - Date of Submission 3. June 6, 2005 - Device Trade name, Common Name 4. REGIUS RS-1000, Medical Image Processing Workstation - 5. *Classification Class II, 90-LLZ, 21CFR 892.2050, Picture archiving and communications system - Intended Use 6. Receive and process electronic images of patients - 7. Applicable mandatory and voluntary standards REGIUS RS-1000 complies with the following mandatory and voluntary standards - · Information Technology Equipment Part 1: General Requirements for Safety UL Standard 60950 - · Information Technology Equipment, Radio Disturbance (Emissions) Characteristics Limits and Methods of Measurement, IEC/CISPR 22 (EN55022) - · Information Technology Equipment, Immunity Characteristics Limits and Methods of Measurement, IEC/CISPR 24 (EN55024) - · DICOM (Digital Imaging and Communications in Medicine) Developed by the American College of Radiology and the National Electrical Manufacturers Association {1}------------------------------------------------ #### 8. Description of Device REGIUS RS-1000 is Konica Minolta Image Quality Control Terminal. REGIUS RS-1000 has the hard disk for storing the digital images. REGIUS RS-1000 consists of a workstation computer with keyboard and mouse for input, LAN interface for communication, color or monochrome CRT or LCD for displaying. REGIUS RS-1000 processes the images received from a single or multiple CR (Computed Radiography) devices with the auto gradation processing function, etc. and outputs them to one or multiples storage devices, such as the host computer or a film printer. - Note) This product is designed intended for exclusive use with a radiographer, and not for the purpose of doctor's diagnosis. #### The REGIUS RS-1000 has the following feature. - 1. The function to do an image processing to the image data received from the CR modalities. - The kinds of the image processing are as follows: - 1) Adjusting the Contrast: - Achieve a clearly depicted image (with clear minimum density). - 2) Re-sampling and Resizing - The function that re samples and resizes the image data according to need. - 3) F-processing: Improve dill or poorly modulated (lacking in contrast) images (to give definition to details). These process doses not affect density. - 4) E-processing: To improve the image that is not possible to be fully expressed by the film latitude due to the wide distribution of the subject. - 5) H-processing Hybrid processing is frequency enhancement processing and equalization processing based on multi-resolution analysis. - 6) Masking Fills in black the area on the frame where the X ray is not irradiated. - 7) Stitching This function that manually or automatically recognizes the long body part and assists the user to stitch each body part to create a composite image. The user checks all alignments done automatically. The image can be divided into several small images before output to a storage device or film printer. Note) This feature requires cassette type CR in addition connected. - 2. The function that displays all information attached with the medical image, such as patient related information, study information, and so on. The ability to confirm, modify or update this information manfully or by connecting to RIS (Radiology Information System) or HIS (Hospital Information System) is also provided. - 3. Images belong to the same study can be separated into different studies when necessary, and the different studies also be combined into a single study. - 4. The function to add or modify digital marker, grid, scale, and so on. - 5. The function that stores images data temporary before transferring them any further. Oldest images will be erased automatically to make sure of the hard disk capacity for continuously operation. - 6. The function that outputs the image data to a storage device, such as PACS (Picture Archiving and Communication System), and a film printer. - 7. The function that retrieves past image data from a storage device. The retrieved image data may be re-processed then output to a film printer and so on. {2}------------------------------------------------ ### 9. Diagram of Layout and Interconnections The figure of the layout and the mutual connection of the system Image /page/2/Figure/2 description: The image shows a diagram of a network configuration. On the left side, there is a box labeled "REGIUS RS-1000". A line connects this box to a central point labeled "Ethernet (IEEE802.3*)". From this central point, four lines extend to the right, each connecting to a box labeled with different devices: "HIS, RIS *1", "Printer *2", "PACS, Viewer *3", and "REGIUS, CR *4". - *1) DICOM Modality Worklist Information Model · FIND DICOM Modality Performed Procedure Step SOP Class - *2) DICOM Basic Grayscale Print Management Meta SOP Class - *3) DICOM Computed Radiography Image Storage - *4) DICOM Computed Radiography Image Storage Grayscale Softcopy Presentation State Storage SOP Class DICOM Storage Commitment Push Model SOP Class - 10. Safety Information REGIUS RS-1000 introduces no new safety and efficacy issues other than those already identified with the predicate device. The results of a hazard analysis, combined with the appropriate preventive measure taken indicate that the device is of minor level of concern as per the "Guidance for the Content of Premark Submissions for Software Contained in Medical Devices". {3}------------------------------------------------ ## 11. Substantial Equivalence to Predicate Device The REGIUS RS-1000 is substantially equivalent to Fuji CR Console Plus (Flash Plus IIP), 510(k) number: K041990. Comparison of the principal characteristics of the two devices which are pertinent to specification performance is shown below. | 1)<br>Hardware | |----------------| |----------------| | | Medical Device Applied<br>for approval | | Approved Medical Device<br>Approval No. K041990 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Feature | REGIUS RS-1000 | Fuji Flash Plus IIP | | | Minimum Basic<br>Computer<br>Configuration | Computer "Off the Shelf"<br>Desktop or Tower<br>· CPU: Pentium 4<br>· Bus: PCI<br>· RAM: 1024MB<br>· Hard Drive: 40GB<br>· Floppy Drive: 3.5"<br>· CD-ROM<br>· Keyboard<br>· Mouse | Computer "Off the Shelf"<br>Desktop or Tower<br>· CPU: Pentium 4<br>· Bus: ISA/PCI<br>· RAM: 512MB<br>· Hard Drive: 40GB<br>· Floppy Drive: 3.5"<br>· CD-ROM<br>· Keyboard<br>· Mouse | | | Operating System Software | Microsoft Windows 2000<br>or Windows XP | Microsoft Windows 2000<br>or Windows XP | | | Ethernet Capability & Type | Yes:LAN | Yes:LAN | | | Image transfer | via DICOM 3.0 &<br>Via proprietary protocol | via DICOM 3.0 &<br>Via Fuji DMS Network | | | Image Display | 16" color 1MP LCD | 19" color 2MP LCD<br>with Touch screen | | | Image processing functions | Yes, enhanced | Yes, enhanced | | | Image viewing &<br>orientation functions | Yes, enhanced | Yes, enhanced | | | Connects to Image Recorders<br>(Printers) | Yes | Yes | | 2) Software | | | | | Feature | REGIUS RS-1000 | Fuji Flash Plus IIP | | | Image<br>processing | a. F-processing<br>F-Processing is a form of image processing which modifies image spatial frequency characteristics, so that structures of body parts are displayed more sharply. | a. Gradation/Edge enhancement<br>Along with gradation, edge enhancement as well as DRC Fuji image processing makes image quality consistently good, so the technologist spends less time manipulating the image. | Same as the approved device | | | b. E-processing<br>E-processing allows an image with a wide dynamic range to be converted to one with a smaller dynamic range which is easier to view. | b. DRC (Dynamic Range Control)<br>DRC improves visualization of areas with different densities in the same image. | Same as the approved device | | | c. H-processing<br>H-Processing is the method of frequency Processing that uses the resolution of the image in multi resolution space. This adjusts the sharpness of the image and compress the dynamic range. | c. MFP (Multi-objective Frequency Processing)<br>MFP enables enhancement of both small and large structures at the same time as well as better visualization of areas with different densities. | Same as the approved device | | | d. Masking<br>Masking blacks out areas outside the field of X-ray exposure on the image. | | Additional feature | | | e. Re-sampling and Resizing<br>The functions change the resolution of the image, using digital image interpolation according to need. | | Additional feature | | | f. Stitching<br>Stitching assembles the composite image from the images read out the photostimulated luminescence plates which had been positioned such that the two adjacent plates overlap each other at the exposure. This manually or automatically adjusts the image positions which are matched with each other. | | Additional feature | {4}------------------------------------------------ ## 2) Software · . : {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Côrporate Boulevard Rockville MD 20850 Konica Minolta Medical & Graphic, Inc. % Mr. Shinichi Yamanaka Safety Department Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun Mie-ken, 519-05 JAPAN Re: K051521 JUN 2 8 2005 Trade/Device Name: Medical Image Processing Workstation, REGIUS RS-1000 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 6, 2005 Received: June 14, 2005 Dear Mr. Yamanaka: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known) : K ە ﻛ ﺍ ﻛ ﻛ ﻛ ( Medical Image Processing Workstation, REGIUS RS-1000 : Device Name Indications For Use: Receive and process electronic images of patients. The REGIUS RS-1000 is NOT intended for use with digital mammography system. Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Broadon Page 1 of (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K051521